FDA 510(k) Application Details - K222978

Device Classification Name	More FDA Info for this Device
510(K) Number	K222978
Device Name	Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
Applicant	Xiros Ltd Springfield House Lane, Whitehouse Lane Leeds LS17 7UE GB Other 510(k) Applications for this Company
Contact	Steve Curran Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QUW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2022
Decision Date	12/27/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review